subject: FDA Alludes to Research That Prompted Users to Seek Fixodent Lawsuit Settlements [print this page] FDA Alludes to Research That Prompted Users to Seek Fixodent Lawsuit Settlements
Individuals seeking a Poligrip or Fixodent lawsuit settlement will be interested to learn that the FDA issued a notice recently to denture cream manufacturers that included recommended actions meant to mitigate the negative effects of denture adhesives on public health.
Specifically, the Food and Drug Administration (FDA), in issuing a document entitled "Notice and Recommended Action" to denture adhesive manufacturers, addressed denture creams containing zinc, which studies have shown may result in zinc toxicity and neurological damage when users are overexposed to them. Among the factors contributing to adverse events caused by denture cream zinc, the FDA cites the absence of package labeling naming zinc as an ingredient, the ignorance of the general public concerning the dangers of zinc overconsumption, and potentially misleading product labeling that could result in users' improperly applying denture cream.
In an effort to remedy what it is calling a "public health issue" the FDA makes a number of recommendations to companies that produce denture cream, including conducting studies to measure how well consumers understand denture cream labeling and the potential to misuse the product, modifying labels to provide clear instructions for safe use, and removing zinc from their products.
GlaxoSmithKline, which manufacturers Poligrip, already announced that it would reformulate several of its Super Poligrip products to be zinc-free last year. While Procter & Gamble, maker of Fixodent, has yet to take similar action, a company spokeswoman said: "[W]e take the FDA's issued letter very seriously providing safe products for consumers is our number one priority." There are also numerous brands of denture cream made by generic manufacturers, some of which could contain zinc.
The FDA's notice to denture adhesive manufacturers comes amidst a growing number of lawsuits filed against GSK and P&G by injured denture cream users suffering from symptoms such as difficulty walking, tingling in the extremities, pain, weakness, and paralysis. The suits allege that the manufacturers failed to provide sufficient warning of their products' toxicity and designed unsafe products.
Prior to the 2008 publication of a study by University of Texas researchers linking the zinc contained in denture cream to neurological disease, neither GSK nor P&G listed zinc as a product ingredient. Although FDA regulations did not require them to do so, it could still be argued that the companies disregarded the health of users by failing to disclose that their products contained a potentially toxic component. And while products like Fixodent now list zinc as an ingredient and have revised instructions for proper use, some argue that simply stating "Start with a small amount at first" (the directions supplied with packages of Fixodent) doesn't go far enough.
Such matters will ultimately be up to the courts to decide. GSK settled two zinc poisoning lawsuits in 2006, but the current lawsuits against it and P&G are far from being resolved. A bellwether Fixodent trial is scheduled for June, at which time judicial decisions could be made that affect the future of Poligrip and Fixodent lawsuit settlements. In the meantime, don't hesitate to contact the Rottenstein Law Group about any denture cream lawsuit questions you may have.
